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Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00723060
First received: July 24, 2008
Last updated: August 5, 2011
Last verified: August 2011
History of Changes

July 24, 2008
August 5, 2011
September 2008
January 2011   (final data collection date for primary outcome measure)
The difference of Y-BOCS score average from baseline to 16-week [ Time Frame: baseline and16-week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00723060 on ClinicalTrials.gov Archive Site
1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A [ Time Frame: every 2 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study)

OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).

OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
Drug: escitalopram
escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
  • Active Comparator: 1
    escitalopram high dose group
    Intervention: Drug: escitalopram
  • Active Comparator: 2
    escitalopram conventional group
    Intervention: Drug: escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Man or woman, aged 18 to 65 years, outpatient
  2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
  3. Severity: Y-BOCS score of >= 20 at screening and baseline
  4. No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
  5. Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.

Exclusion Criteria:

  1. primary active DSM-IV axis I diagnosis other than OCD
  2. History of substance, including alcohol, dependence and psychotic symptoms
  3. Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
  4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
  5. History of no response to escitalopram or citalopram treatment
  6. History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
  7. Women who are pregnant, planning to become pregnant, or breast-feeding
  8. Ongoing cognitive behavior therapy (CBT) of OCD
  9. Hoarding or collecting type
  10. Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00723060
11769A
Yes
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Jun Soo Kwon, M.D., Ph.D. Seoul National University Hospital, Seoul, Korea
Seoul National University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP